Identity
- Trade Name
- BiCart 720 EUDAMEDBiCart FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Device Name
- BiCart EUDAMEDSodium Bicarbonate for Hemodialysis FDA UDI
- Model / Reference
- 109733 EUDAMED720 FDA UDI
- Description
- Sodium Bicarbonate for Hemodialysis FDA UDI
Identifiers
- Catalog Number
- 109733 FDA UDI
- Primary DI / UDI-DI
- 07332414088316 EUDAMEDFDA UDI
- Basic UDI-DI
- 7332414VA0000393A EUDAMED
- 510(k) Number
- K013724 FDA UDI
- FDA Product Code
- KPO FDA UDI
- EMDN Code
- F040201 DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER EUDAMED
- GMDN Term
- Haemodialysis concentrate FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 720 Gram FDA UDI
Category: Haemodialysis concentrate
BiCart by Vantive Health GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis concentrate.
- DIASOL — DIASOL INC · Class II
- CitraPure — Rockwell Medical · Class II
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC. · Class II
- Di-Chem Hemodialysate Additive — Di-Chem, Incorporated · Class II
- Hemo-Dial — EDLAW PHARMACEUTICALS, INC. · Class II
- CitraPure — Rockwell Medical · Class II
- Centrisol Acid Concentrate — MEDIVATORS INC. · Class II
- DIASOL — DIASOL INC · Class II
Cleared under the same submission
K013724 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vantive Health GmbH
Sources (2)
- FDA UDI 188c069a-0101-4c79-9297-dad36840e2fb 38 fields · synced Jun 19, 2026
- EUDAMED 9ec3fd3a-4dba-46ad-a0ee-f3e233fe2458 61 fields · synced Jun 19, 2026